An Open Label, Randomized Phase I/IIa Trial Evaluating MK0646 in Combination With Erlotinib for Patients With Recurrent Non-Small Cell Lung Cancer
18 Years
N/A
Both
Carcinoma, Non-small-cell Lung
Trial Information
An Open Label, Randomized Phase I/IIa Trial Evaluating MK0646 in Combination With Erlotinib for Patients With Recurrent Non-Small Cell Lung Cancer
- Dalotuzumab is a humanized monoclonal antibody (mAb) that targets the IGF-1R
- Dalotuzumab may act through
- Inhibition of IGF-1-mediated cell signaling to cause reductions in tumor growth
and spread
- Antibody dependent cell-mediated cytotoxicity
- In preclinical studies, dalotuzumab improved the activity of an anti-EGFR mAb and
the activity of Erlotinib, a small molecule inhibitor of EGFR
Trial Duration of Treatment: Subjects will continue on the study for as long as their
disease is not progressing and they do not have unmanageable side effects from the
treatment.
Inclusion Criteria:
- Subject has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer
that has relapsed after chemotherapy/chemoratiotherapy.
- Subject has had at least one chemotherapy regimen for recurrent or metastatic
disease.
- Subject is 18 years of age or older
- Subject has a performance status of 0-2 on ECOG scale.
- Women of childbearing potential have a negative pregnancy test
Exclusion Criteria:
- Subject has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab)
within 4 weeks
- Subject has not recovered from adverse events from previous therapy within 4 weeks
- Subject has received EGFR-TKI inhibitor/anti-EGFR mAb therapy
- Subject has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
- Subject has had more than 2 systemic chemotherapies for metastatic disease
- Subject has not completed radiotherapy with complete resolution of toxicities at
least 2 weeks before starting in the study
- Subject is taking part in another clinical study
- Subject has a primary central nervous system tumor
- Subject abuses drugs or alcohol
- Subject is pregnant or breastfeeding
- Subject is HIV positive
- Subject has a history of hepatitis B or C
- Subject is using growth hormone or growth hormone inhibitors
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability of the combination treatment; progression-free survival will be assessed using physical examinations, vital signs, ECOG performance status, complete blood count with differential and platelets, serum chemistry, adverse experience
Outcome Time Frame:
After each dose of study drug
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
2007_605
NCT ID:
NCT00654420
Start Date:
March 2008
Completion Date:
February 2012
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|
